YES TO CUCUMBERS NATURAL SUNSCREEN SPF 30 STICK- zinc oxide, titanium dioxide stick 
Autumn Harp, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Yes To Cucumbers Natural Sunscreen SPF 30 Stick

Active Ingredient

Zinc Oxide (10.8%) Titanium Dioxide (4.9%)

Purpose

Sunscreen

Uses

Helps prevent sunburn • Higher SPF gives more sunburn protection • Provides high protection against sunburn

Warnings:

For external use only.  When using this product avoid contact with eyes • If contact occurs, rinse with water to remove.  Stop use and ask Doctor if rash or irritation develops and lasts.  Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center immediately. 

Directions

Apply liberally and evenly 15 minutes before sun exposure • reapply after 40 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours • Children under 6 months of age, ask doctor.

Sun Protection Measure

Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long-sleeved shirts, pants, hats, and sun-glasses.

Inactive Ingredients

Beeswax, Ethylhexyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Ethyl Palmate*, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Fragrance, Polyglyceryl-3 Diisostearate, Aluminum Hydroxide, Helianthus Annuus (Sunflower) Seed Oil, Hydrated Silica, Triethoxycaprylylsilane, Tocopherol, Cucumis Sativus (Cucumber) Seed Extract*.  * Certified Organic Ingredient

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YES TO CUCUMBERS NATURAL SUNSCREEN SPF 30 STICK 
zinc oxide, titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.8 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYL PALMATE (UNII: PY7890FR5M)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CUCUMBER (UNII: YY7C30VXJT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SOYBEAN OIL (UNII: 241ATL177A)  
cucumber seed (UNII: BT3S9L53JK)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0315-115 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/11/2013
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0315)

Revised: 9/2013
Document Id: 8f3e090a-3d0e-479c-ac5b-8a3dd69ecc00
Set id: 99a522f3-0931-4ced-84a6-6123cf34f79a
Version: 1
Effective Time: 20130925
 
Autumn Harp, Inc.